# K981351: Candela Gentlelase GL Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jul 13, 1998 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963094 (1996). 5 ancestors in all.
811 later devices descend from it; 5 cite it directly.
0 of 817 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974381: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K963094: Cynosure Photogenica LP Dermatological Vascular Lesion Laser, Cynosure, Inc. (1996) Summary page 1.
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.
- K971874: Sharplan Epitouch Alexandrite Laser System (5000), Sharplan Lasers, Inc. (1997). Our OCR of the scanned summary read K971784, FDA’s number for Zeus Scientific, Inc., Anticardiolipin Igg/Igm Elisa Test… (Zeus Scientific, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Sharplan Model 5000 Laser”.

## Most influential descendants
- K991798: Acme Medical Aesthetic ND:Yag Laser (2000), 745 descendants of its own
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own
- K023193: Candela Gentle Yag Laser System (2002), 656 descendants of its own

## Indications for use
The Candela GentleLase GL Dermatology Laser is indicated for the following uses: 1. the Photocoagulation of Dermatological vascular lesions. 2. the removal of hair.

Source page: https://510kreport.com/device/K981351
Methodology: https://510kreport.com/methodology